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| Product NDC Code | 37000-997 | ||||
|---|---|---|---|---|---|
| Drug Name | Vicks formula 44 cough drops |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | LOZENGE | ||||
| RxCUI drug identifier | 476973 | ||||
| Application Number | M022 | ||||
| Labeler Name | The Procter & Gamble Manufacturing Company | ||||
| Packages |
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Overdosage of Vicks Formula 44 Cough Drops
Information about signs, symptoms, and laboratory findings of acute ovedosage and the general principles of overdose treatment.In case of overdose, get medical help or contact a Poison Control Center right away
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient (per drop) Menthol 5.8 mg
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions adults and children 12 years and over: dissolve 1 drop slowly in the mouth. Repeat every 2 hours as needed or as directed by a doctor. children under 12 years of age: do not use
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients corn syrup, eucalyptus oil, FD&C Red No. 40, flavors, sucrose, water
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses temporarily relieves: cough associated with a cold occasional minor irritation or sore throat
Purpose
Information about the drug product’s indications for use.Purpose Cough suppressant/Oral anesthetic
Spl product data elements
Usually a list of ingredients in a drug product.Vicks Formula 44 Cough Drops Menthol CORN SYRUP FD&C RED NO. 40 EUCALYPTUS OIL WATER MENTHOL MENTHOL SUCROSE VICKS menthol
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.PRINCIPAL DISPLAY PANEL - 50 Drop Bag VICKS ® FORMULA 44™ COUGH DROPS MENTHOL • Cough Suppressant / Oral Anesthetic Cooling Menthol Soothes Sore Throat Relieves Cough actual size 50 MEDICATED DROPS 997
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
DIST. BY PROCTER & GAMBLE, CINCINNATI, OH 45202
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Ask a doctor before use if you have persistent or chronic cough such as occurs with smoking, asthma, or emphysema cough accompanied by excessive phlegm (mucus) a severe sore throat accompanied by difficulty in breathing or that lasts more than 2 days
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? 1-800-342-6844
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor if cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. sore mouth symptoms do not improve in 7 days irritation, pain, or redness persists or worsens
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health professional before use.
Storage and handling
Information about safe storage and handling of the drug product.Other information Store at 20°- 25°C (68°-77°F) in a dry place Contains soy
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings Sore Throat Warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult doctor promptly. Do not use more than 2 days or administer to children under 12 years of age unless directed by doctor. Ask a doctor before use if you have persistent or chronic cough such as occurs with smoking, asthma, or emphysema cough accompanied by excessive phlegm (mucus) a severe sore throat accompanied by difficulty in breathing or that lasts more than 2 days Stop use and ask a doctor if cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. sore mouth symptoms do not improve in 7 days irritation, pain, or redness persists or worsens If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API